External eye-contact device having opaque and decentered light-transmissive portions

ABSTRACT

Embodiments concern an optical eye-contact device comprising a lens body having a symmetry axis and which further comprises a light-transmissive portion and an opaque portion, wherein the light-transmissive portion is decentered with respect to the symmetry axis.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority from U.S. Provisional PatentApplication No. 62/301,798 filed on Mar. 1 2016, titled “ArtificialExternal Contact Lens with Decentered Aperture for Deflecting Lights”and which is expressly incorporated herein by reference in its entirety.

TECHNICAL FIELD AND BACKGROUND

The Macula describes an area on the retina of the human eye which isresponsible for sharp central vision due to the comparatively highreceptor density. Age-related Macular Degeneration, also known as AMD,degenerates macular tissue and thus reduces the density of receptors,causing severe disruption of vision acuity in patients. Therefore,patients suffering from AMD often heavily rely on peripheral vision fordaily tasks. However, the peripheral retina has low receptors densitiesrelative to the macula, which leads to a lower resolution ability.

The fovea is a localized region of the macula with the highest visualacuity, close to the optic axis of the eye, where the inner layers ofthe retina are absent. Macular degeneration is most debilitating when itdisrupts the fovea.

Related Art Documents Include:

[1] U.S. Pat. No. 4,955,902A

[2] US2002019667A

[3] US2012136438A

[4] US2013211515A

[5] US2016193039A

[6] WO15006839A1

[7] US2004117013A

[8] U.S. Pat. No. 6,197,057B

[9] U.S. Pat. No. 4,581,031A

[10] US2006187409A

[11] US2010265458A

[12] U.S. Pat. No. 6,139,145A

[13] US2004082995A

[14] US2002052652A

[15] US2011153014A

Acknowledgement of the above related art documents is not to be inferredas meaning that these are in any way relevant to the patentability ofthe presently disclosed subject matter.

The description above is presented as a general overview of related artin this field and should not be construed as an admission that any ofthe information it contains constitutes prior art against the presentpatent application.

OVERVIEW

Example 1 includes an optical eye-contact device comprising a contactlens body having a rotational symmetry axis, the contact lens bodycomprising a light-transmissive portion and a distal and proximal devicesurface; and an opaque portion which is non-transmissive to visiblelight, wherein the light-transmissive portion is decentered with respectto the contact lens body's symmetry axis and allows a portion of lightincident on the distal surface to propagate from the distal devicesurface via the light-transmissive portion and emanate from the proximaldevice surface.

Example 2 includes the subject matter of example 1 and, optionally,wherein when the contact lens body operably engages an eye of a patient,the symmetry axis of the eye-contact device coincides with the eye'soptical axis.

Example 3 includes the subject matter of example 2 and, optionally,wherein the contact lens body comprising the light-transmissive portionis configured such that light propagating through the light-transmissiveportion is incident onto the patient's macula but not on the fovealocated in the macula.

Example 4 includes the subject matter of example 2 and, optionally,wherein the contact lens body which comprises the light-transmissiveportion is configured so that light propagating through thelight-transmissive portion is incident onto on an area of the patient'sretina that is outside the macula.

Example 5 includes the subject matter of any one of the examples 1 to 4and, optionally, wherein the contact lens body is configured to at leastpartially or fully compensate for refractive errors of the patient'seye.

Example 6 includes the subject matter of example 5 and, optionally,wherein the light-transmissive portion has a concave or convex shape.

Example 7 includes the subject matter of example 5 or 6 and, optionally,wherein the contact lens body is configured to at least partiallycompensate for myopia of the patient.

Example 8 includes the subject matter of any one of the examples 1 to 7and, optionally, wherein the light-transmissive portion comprises solidor gel-based material.

Example 9 includes the subject matter of any one of the examples 1 to 8and, optionally, wherein the light-transmissive portion comprises fluidmaterial.

Example 10 includes the subject matter of example 9 and, optionally,wherein the fluid material comprises air, gas and/or liquid material.

Example 11 includes the subject matter of any one of the examples 1 to 4and, optionally, wherein the light-transmissive portion is a physicalthrough-hole that extends from the distal to the proximal devicesurface.

Example 12 concerns a trial kit comprising a plurality of trialeye-contact devices each having different values relating to opticaldesign parameters of the trial eye-contact devices such to allow a userof the trial kit to sequentially select at least two of the plurality oftrial eye-contact devices for implementing an iterative optimizationprocess in which the parameter values are convergent until for the givenplurality of trial eye-contact devices, a combination of deviceparameters is determined that is considered optimal for the givenpatient.

Example 13 concerns a method for manufacturing an optical eye-contact,comprising receiving information pertaining to a condition of apatient's eye; and providing, based on the received information, anoptical eye-contact device.

This overview introduces a selection of concepts in a simplified formthat are further described below in the Description of the Figures andthe Detailed Description. This Overview is not intended to identify keyfeatures or essential features of the claimed subject matter, nor is itintended to be used to limit the scope of the claimed subject matter

BRIEF DESCRIPTION OF THE FIGURES

The figures illustrate generally, by way of example, but not by way oflimitation, various embodiments discussed in the present document.

For simplicity and clarity of illustration, elements shown in thefigures have not necessarily been drawn to scale. For example, thedimensions of some of the elements may be exaggerated relative to otherelements for clarity of presentation. Furthermore, reference numeralsmay be repeated among the figures to indicate corresponding or analogouselements. References to previously presented elements are impliedwithout necessarily further citing the drawing or description in whichthey appear. The number of elements shown in the Figures should by nomeans be construed as limiting and is for illustrative purposes only.The figures are listed below

FIG. 1A is a schematic isometric side view illustration of aneye-contact device operable engagement with a patient's eye, accordingto some embodiments;

FIG. 1B is a schematic front view illustration of the eye-contactdevice, according to some embodiments;

FIG. 1C is a schematic cross-sectional side view illustration of theeye-contact device in operable engagement with the patient's eye beforeexpansion of the eye's pupil, according to some embodiments;

FIG. 1D is a schematic cross-sectional side view illustration of theeye-contact device in operable engagement with the patient's eye afterexpansion of the eye's pupil, according to some embodiments;

FIG. 2A is a schematic partial cross-sectional view of the eye-contactdevice of FIG. 1B;

FIG. 2B is a schematic side-view illustration of an eye-contact device,according to some other embodiments;

FIG. 3A is a schematic and more detailed side view illustration of theeye-contact device in operable engagement with a patient's eye beforeexpansion of the eye's pupil, according to some embodiments;

FIG. 3B is a schematic and more detailed side view illustration of theeye-contact device in operable engagement with a patient's eye afterexpansion of the eye's pupil, according to some embodiments;

FIG. 4 is a flow chart of a method for manufacturing an eye-contactdevice, according to some embodiments;

FIGS. 5A and 5B are schematic illustrations of a trial kit, according tosome embodiments; and

FIG. 6 is a schematic flow chart of a method for obtaining informationpertaining to the clinical condition of a patient's eye, according tosome embodiments.

DESCRIPTION

Aspects of embodiments of disclosed herein relate to devices and methodsfor alleviating complications caused by age-related macular degeneration(AMD) and/or other ophthalmic (including, e.g., neuro-ophthalmic)conditions or diseases of a patient. Accordingly, while certainembodiments may herein be described with respect to AMD, this should byno means be construed in a limiting manner.

The following description of devices, kits and methods for alleviatingophthalmic conditions is given with reference to particular examples,with the understanding that such devices, kits and methods are notlimited to these examples. It should be noted that the terms “device”,“eye-contact device”, “external eye-contact device”, “opticaleye-contact device” and “definite eye-contact device” may herein be usedinterchangeably. It is noted that the term “definite eye-contact device”may herein be used in some instances to distinguish it from “trialeye-contact devices” which may be employed, e.g., as part of a trialmethod or method for obtaining information pertaining to the (e.g.,clinical) condition of a patient's eye, to determine the values relatingto device design and/or manufacturing parameters (e.g., opticalparameters and/or design parameters) suitable for a given patient forthe manufacturing of a “definite” eye-contact device that is customfitted to the given patient according to the determined values.

Reference is made to FIGS. 1A to 1D. An optical eye-contact device 100(also: external contact lens) comprises according to some embodiments acontact lens body 102 which may have a spherical shape and, e.g., covera surface area which may be smaller than that of a hemisphere. The term“spherical” as used herein may also encompass the meaning of the term“substantially spherical”.

Contact lens body 102 may have a distal or outer (e.g., at leastpartially convex) device surface 103A which, when contact lens body 102is operably engaged with a patient's eye 200, may be exposed directly toambient light, and a proximal or inner (e.g., at least partiallyconcave) device surface 103B adapted to allow contact lens body 102 tooperably engage with the anterior surface of the patient's eye 200. Itis noted that the eye-contact device may be considered to be an“external eye-contact device” to exclude intra-ocular implants.Eye-contact device 100 may be exchangeable by the patient himselfmanually like regular contact lenses, e.g., as known in the art, withoutrequiring the assistance of professional medical staff.

Contact lens body 102 may have a rotational symmetry axis or symmetry ofrevolution around axis Z_(device). In an embodiment, contact, lens body102 comprises a light-transmissive portion (also: area) 104 and anopaque portion or area 106 that is non-transmissive to visible light.Optionally, light-transmissive portion 104 and opaque portion 106complement each other to form contact lens body 102. Light-transmissiveportion 104 allows the transmission of light from distal device surface103A to proximal device surface 103B of eye-contact device 100. In oneembodiment, opaque portion 106 is non-transmissive to visible light or,otherwise stated, fully opaque to visible light 50.

Light-transmissive portion 104 is located off-center, off-axis ordecentered with respect to the contact lens body's symmetry axisZ_(device) by a radius R1.

Except for decentered light-transmissive portion 104, contact lens body102 may be opaque to visible light. Accordingly, as schematically shownin FIG. 1A, light 52 that is incident onto opaque portion 106 may beabsorbed by and/or reflected from opaque portion 106. Light reflectedfrom opaque area is herein referenced by alphanumeric designation “54”.

Further reference is made to FIG. 2A. FIG. 2A schematically shows apartial cross-sectional view of eye-contact device 100 along virtualsurface A-A schematically shown in FIG. 1B. Light-transmissive portion104 of contact lens body 102 may extend over a length L_(transmissive)from a distal end 105A to a proximal end 105B. The terms “proximal” and“distal” as used herein refer to positions relative to eye 200 duringnormal use of eye-contact device 100. In some embodiments, distal end105A and/or proximal end 105B may be defined by respective distal and/orproximal surfaces.

Optionally, eye-contact device 100 may be configured such that when itis operably engaged with eye 200, the contact lens body's symmetry axisZ_(device) may coincide with the patient's normal optical axis Z_(eye).The term “coincide” as used herein may also encompass the meaning of theterm “substantially coincide”.

Distal device surface 103A may comprise distal end 105A, and proximaldevice surface 103B may comprise proximal end 105B of light-transmissiveportion 104. Light-transmissive portion 104 allows propagation of light50 incident onto distal device surface 103A to propagate over thedistance D and further via proximal device surface 103B, towards retina202 of the patient's eye 200.

Light-transmissive portion 104 may define an alternative optical axisZ_(alt). Optionally, alternative optical axis Z_(alt) may run parallelto the contact lens body's symmetry axis Z_(device). Optionally,alternative optical axis Z_(alt) may form an angle with respect to thecontact lens body's symmetry axis Z_(device). Optionally, alternativelyoptical axis Z_(alt) may run partially parallel and partially angledwith respect to the contact lens body's symmetry axis Z_(device).

It is noted that the direction of incoming light 50 as shown in theaccompanying figures should not be construed in a limiting manner and isfor illustrative purposes. Accordingly, light 50 may enterlight-transmissive portion 104 from a variety of angles relative toZ_(alt).

In some embodiments, when eye-contact device 100 is set in operableposition, alternative optical axis Z_(alt) may run parallel to theoptical axis of eye 200 (Z_(eye)). In some embodiments, when eye-contactdevice is set in its operable position, alternative optical axis Z_(alt)may form an angle with respect to the optical axis of eye 200 (Z_(eye)).

In some embodiments, when eye-contact device is set in operableposition, an angle formed between the alternative optical axis Z_(alt)and the optical axis of eye 200 and/or of the symmetry axis Z_(device)may be such so that the axes are convergent towards the patient's retina202. In some embodiments, when eye-contact device is set in operableposition, an angle formed between the alternative optical axis Z_(alt)and the optical axis of eye 200 and/or of the symmetry axis Z_(device)may be such so that the axes are divergent towards the patient's retina202.

In some embodiments, the boundaries (e.g., inner walls) oflight-transmissive portion 104 may be formed to be convergent towardsretina 202 when eye-contact device 100 is set in operable position. Insome embodiments, the boundaries (e.g., inner walls) oflight-transmissive portion 104 may be formed to be divergent towardsretina 202 when eye-contact device 100 is set in operable position.

Radius R1 between Z_(device) and Z_(alt) may for example range from 1.5mm to 3 mm. As shown schematically in FIG. 2A, light-transmissiveportion 104 may have a lateral extension d_(transmissive) (e.g.,diameter in case of a circular cross-sectional geometry) ranging, forexample, from 0.3 mm to 5 mm. Optionally, light-transmissive portion 104ay comprise or be made of multiple “small” light-transmissive portions(not shown).

In some embodiments, it may be required to expand iris 206 of eye 200 towiden pupil 207 for allowing the propagation of light 50 vialight-transmissive portion 104 via pupil 207 without hitting or beingobstructed by iris 206. FIG. 1C schematically shows iris 206 beforeexpansion, in the narrow state, so that light 50 entering eye 200through or via light-transmissive portion 104 is incident onto iris 206.FIG. 1D schematically shows iris 206 after its expansion (i.e., in theexpanded state) so that light 50 entering eye 200 through or vialight-transmissive portion 104 can propagate via pupil 207 towardsretina 202. Pupil 207 may be expanded to attain a diameter of at least 6mm, at least 7 mm, at least 8 mm, or at least 9 mm. Expansion of pupil207 may for example be imparted onto iris 206 from an initial pupildiameter of 2-4 mm. Broken circular line 2207 in FIG. 1A schematicallyshows the boundary of pupil 207 relative to eye-contact device 100 whenin operable position and when patient's pupil(s) 207 is/are dilated.

Expansion of iris 206 may be accomplished in a number of ways including,for example, by applying dilating eye-drops to eye 200. Non-limitingexamples of pupil dilating eye-drops include, for example, Tropicamideand Atropine. Tropicamide may be employed when it is desired to effectpupil dilation for a time period of about 3-4 hours, and Atropine may beemployed when it is desired to effect pupil dilation for a time periodfor 10-14 days. In some embodiments, pupil 207 may be expanded in asurgical manner.

Light-transmissive portion 104 may be positioned relative to or at adistance from the contact lens' symmetry axis Z_(device) and at anorientation relative to the patients' retina 202, such that at leastsome of light 50 propagating through light-transmissive portion 104 isincident onto a new main vision spot 203 of the patient's retina 202which is not yet or only partially damaged due to AMD and/or otherophthalmic diseases. Optionally, light 50 propagating throughlight-transmissive portion 104 may be focused onto new main vision spot203. New main vision spot 203 may refer to a vision area of retina 202having a radius ranging (optionally taking into account the retina'scurvature), e.g., from 0.5 mm to 5.5 mm, for the radius of new mainvision spot 203. Eye-contact device 100 is configured and operable suchthat when it is operably engaged with the patient's eye 200, light 50incident onto eye-contact device 50 is directed onto new main visionspot 203, which is displaced or shifted with respect to a spot of thepatient's retina 202 onto which light may normally be focused, which mayherein be referred to as “old main vision spot”. More specifically,light-transmissive portion 104 directs light 50 onto new main visionspot 203, while at the same time, opaque portion 106 prevents light fromentering eye 200. It is noted that the expression “normally” be focusedis not limited to a “naked human eye”, but may also encompass instancesin which a person is wearing prescription spectacles, having acorrective intra-ocular lens and/or the like, e.g., to correct forrefractive errors of eye 200.

The patient's macula 205, which includes the fovea (not shown), may beconsidered to be the “old main vision spot”. Optionally, new main visionspot 203 may be within the area generally considered to be macula 205.Optionally, new main vision spot 203 may be within the area consideredto macula 205, but not on the fovea located in macula 205. Optionally,new main vision spot 203 may be outside the area generally considered tobe macula 205. Merely to simplify the discussion herein, and without beconstrued as limiting, embodiments and/or figures disclosed herein mayrefer to configurations of eye-contact device 100 where light 50 isincident onto an area of retina 202 that is outside macula 205.Optionally, new main vision spot 203 may become an “old” main visionspot, if retina 202 of the new main vision spot 203 becomes damaged suchthat another “new” main vision spot 203 has to be localized and/oridentified.

Causing light 50 to be incident onto new main vision spot 203 mayimprove acuity of patients suffering for instance of AMD or otherdiseases, e.g., from a category that may be considered “legally blind”to above the said category, e.g., “functional”. Exemplarily, acuity ofvision for the respective eye may be increased from 1/60 or 6/60, to6/24, 6/30, 6/15, or to 6/12. Exemplarily, acuity of vision for therespective can be increased by at least 110%, by at least 120%, by atleast 130%, by at least 140%, by at least 150%, by at least 160%, by atleast 170%, by at least 180%, by at least 190%, by at least 200%, or byat least 250%, e.g., with respect to a visual acuity determined, e.g.,by an eye chart, prior to employing eye-contact device 100. In someembodiments, optical eye-contact device 100 may be operative so that,when in operable position, light is focused onto new main vision spot203.

In some embodiments, light-transmissive portion 104 may be implementedby a fluid-sealed aperture (also: a physical hole or a pinhole) formedin contact lens body 102. In some embodiments, light-transmissiveportion 104 may be a physical through-hole extending from distal devicesurface 103A to proximal device surface 103B. Otherwise stated, opaqueportion 106 may form a through-hole 104 in eye-contact lens body 110.

In some embodiments, light-transmissive portion 104 may be afluid-filled (e.g., air-filled, gas-filled, or liquid-filled) cavitythat is, for example, enclosed by the material of contact lens body 102and by distal and proximal ends 105A and 105B, respectively. In someother embodiments, light-transmissive portion 104 of contact lens body102 may comprise solid or gel-based material that is transparent tovisible light. It is noted that the term “transparent” may alsoencompass the meaning of the term “substantially transparent”. In someembodiments, light-transmissive portion 104 may be configured to atleast partially correct or at least partially compensate for optical(e.g., refractive) error(s) of eye 200, including for example, tocompensate for myopia, hyperopia and/or astigmatism of eye 200. In someembodiments, light-transmissive portion 104 may be configured to fullycompensate for optical errors of eye 200.

Light-transmissive portion 104 may be flush with opaque portion 106 oneither side of optical eye-contact device 100. Contact lens body 102 maybe custom fitted to the shape of the patient's cornea 208. Contact lensbody 102 may comprise or be made of any suitable material including, forexample, Rigid gas-permeable (RGP) material such as, for example,fluorosilicone acrylate, or malleable plastic polymers. In someembodiments, contact lens body 102 may have a “scleral” lens body andtherefore be configured to cover most of a patient's sclera 212. In someembodiments, contact lens body 102 may be colored to mimic the naturallook of an eye. In some embodiments, optical eye-contact device 100 maybe configured such to have therapeutic, sensing, monitoring, detection,and/or recording capabilities.

In one embodiment, contact lens body 102 may be sized (e.g., have adiameter, D_(device)) such to be partially covered by the eyelids (notshown) when they are open. In another embodiment, contact lens body 102may be sized to not be covered by the eyelids (not shown) when they areopen. Contact lens body 102 may be configured to cover the cornea 208 inits entirety. Contact lens body 102 may be configured to cover cornea208 in its entirety and 50% or less of the patient's sclera 212.

Location of new main vision spot 203 may refer to the position of anarea on retina 202 at which for a given patient, maximal visual acuityis obtained. It follows from the aforesaid that the location of new mainvision spot 203 on retina 202 may differ between patients. Accordingly,radius R1, lateral dimension d_(transmissive), and/or lengthL_(transmissive) and/or values of additional parameters may becustomized to each patient. Optionally, device diameter D_(device),shape of distal device surface 103A and of proximal device surface 103Bmay be customized for each patient.

The expression “maximal visual acuity” as used herein may optionallyrefer to a visual acuity that is approximately “maximal” within acertain range for a given patient. Optionally, visual acuity a givenpatient's sensory vision threshold may be determined using an eye chart(e.g., Early Treatment Diabetic Retinopathy Study (ETDRS) chart, Snellenchart, LoMar chart, E-chart, Amsler Grid, The Bailey-Lovie Acuity Chart,etc.).

It is noted that a theoretical maximum obtainable visual acuity for agiven patient may not be accurately determinable as it may depend onmany factors which are not accurately measurable and/or controllableincluding, for example, environmental factors, on the testing proceduresperformed, sensitivity of the interpretative faculty of the brain, theresolution and/or type of the eye chart employed, and/or accuracy of theinstruments used in the testing procedure.

In some embodiments, optical eye-contact device 100 may have astabilized design to achieve rotational and translational stability whenoptical eye-contact device 100 is set in operable position. In otherwords, optical eye-contact device 100 may be configured to remainrotationally and translationally stationary with respect to the eye'soptical axis Z when set in operable position.

A stabilized design may be achieved, for example, by designing a bottomportion of optical eye-contact device 100 to be thicker than an upperportion, also known as “prism balance”. By thickening the lower portionof the contact lens, the upper eyelid can slide over the comparativelythin superior portion during blinking, thus forcing the thicker inferiorportion down. In this way, optical eye-contact device 100 may maintain adesired orientation. Optionally, optical eye-contact device 100 may havea mass distribution configured to maintain rotational stability due togravitation.

The shape of distal device surface 103A and of proximal device surface103B shown in the accompanying figures are for illustrative purposes andshould by no means be construed in a limiting manner. FIG. 2Bschematically shows another example of a shape of optical eye-contactdevice 100.

Additional reference is made to FIGS. 3A and 3B. As schematically shownin FIGS. 3A and 3B, light 50 incident onto distal end 105A propagatesthrough light-transmissive portion 104 over a distance L_(transmissive)and exits from proximal end 105B from where light 50 may furtherpropagate through the cornea 208 of eye 200. In FIG. 3A, pupil 207formed by iris 206 is shown in a non-retracted (e.g., non-dilated) statesuch that light 50 is incident onto iris 206, thereby possiblypreventing light 50 from propagating towards retina 202.

FIG. 3B schematically shows pupil 207 of eye 200 in an expanded state(e.g., through dilation). When pupil 207 is in the expanded state, light50 propagating through cornea 208 of eye 200 may pass through pupil 207and further propagate through the eye's lens 210 via the vitreous body(not shown) until incident onto new main vision spot 203.

To simplify the discussion herein, optical refraction and/or diffractionand/or other optical phenomenon relating to light 50 propagating fromdistal end 105A of light-transmissive portion 104 until light 50 isincident onto new main vision spot 203 of retina 202 may herein beneglected.

As already indicated herein, new main vision spot 203 is shifted withrespect to an old vision spot (e.g., temporally, nasally shifted,upwards or downwards in eye 200), which may be macula 205. The lengththe curvature between the center of macula 205 and the center of newmain vision spot 203 may be in the range, for example, from 0.5 mm to 3mm. Light 50 incident onto photo-receptors (not shown) located in newmain vision spot 203 may cause the generation of signals which aretransmitted to the patient's brain (not shown) via optic nerve 214.

Additional reference is made to FIG. 4. A method for manufacturingoptical eye-contact device 100 may include, for example, receivinginformation pertaining to the (e.g., clinical) condition of a patient'seye including, for example, the condition of the patient's retina 202(step 402). In case the patient's visual acuity is adversely affected,e.g., due to AMD, the information may relate to or be descriptive of thelocation where the patient's retina 202 is comparatively intact. Thelocation information may for example be indicative of 61 that is optimalfor the given patient and further indicative of the rotational (also:angular) position of light-transmissive portion 104 (e.g., in terms ofclockwise angular progression).

The method may further include providing, based on the receivedinformation, optical eye-contact device 100 (step 404), Morespecifically, the optical eye-contact device 100 may be provided suchthat the device's operative parameters are adjusted to the receivedinformation pertaining to the clinical condition of the patient's eye.Providing-eye contact device 100 may thus be customized to a givenpatient's specific needs.

Optical eye-contact device 100 may be provided using variousmanufacturing techniques that are based on, for example, printingtechnologies, lathe forming, 3-D contouring, injection molding and/orany other suitable manufacturing techniques.

Information pertaining to the clinical condition of a patient's eye maybe obtained in various manners. For example, the clinical condition of aretina 202 for instance may be determined by employing various imagingtechniques such as, e.g., Optical Coherence Tomography (OCT), FundusPhotography and/or Angiography.

In some embodiments, eye-contact devices 100 may be operable to allow atleast partial correction of refractive errors. For instance,light-transmissive portion 104 may be shaped to at least partiallycorrect for refractive vision errors. For instance, light-transmissiveportion 104 may be configured (e.g., shaped) to correct for myopia,hyperopia and/or astigmatism. Optionally, the surfaces of distal end105A and of proximal end 105B of light-transmissive portion 104 may beshaped in a concave (e.g., biconcave) or convex (e.g., biconvex) mannerwith respect to each other.

Further reference is made to FIG. 5. Aspects of embodiments relate to atrial set (also: trial kit or kit) 500 comprising a plurality of trialeye-contact devices, herein respectively referenced by alphanumericdesignations “510-1” to “510-n”. Each one of the trial-contact devices510-1 to 510-n may possess different design parameters. Trial kit 500may be configured to allow a user thereof (e.g., an ophthalmologistand/or optometrist) to determine which combination of individual designparameters may be most suitable for a given patient. For example, trialkit 500 may be configured to allow the user to employ an iterativeoptimization process in which the parameter values are convergent untilfor the given plurality of trial eye-contact devices 510-1 to 510-n, acombination of device parameters is determined that may be consideredoptimal for the given patient.

Trial kit 500 may allow a user of trial kit 500 to select at least twoof the plurality of trial eye-contact devices 510, and sequentiallyapply the at least two selected trial eye-contact devices on the sameeye of the given patient. The given patient's feedback provided for eachone of the at least two selected trial eye-contact devices 510 may beregistered (e.g., stored automatically in a computer database). Based onthe feedback, the user may select another, trial eye-contact device thatpossesses design parameters which are, in combination, different fromthe (first) at least two selected trial eye-contact devices. Based onthe patient's feedback in response to trying the other eye-contactdevice and the at least two selected trial eye-contact devices, the usermay select a further other trial eye-contact device. Based on thepatient's feedback provided in response to trying the other and thefurther other trial contact-devices, a yet further other trialcontact-device may be selected, and so forth. The user may iterativelyproceed with the above noted steps using trial and error to arrive at acombination of device parameters that is optimal for the given patient.The procedures outlined herein with respect to trial kit 500 may beperformed with the help of slit lamps and/or any other suitableequipment.

It is noted that the term “optimal” as used herein should not beconstrued in a mathematical limiting manner, as the optimal combinationmay vary under different circumstances and depend, for example, onenvironmental factors, on the testing procedures performed, sensitivityof the interpretative faculty of the brain and/or the instruments usedin the testing procedure. The expression “determining” used herein inconjunction with procedures for determining the optimal combination ofvalues relating to device parameters may herein also encompass“heuristically determining”, or “using heuristics”.

Trial eye-contact devices 510-1 to 510-n may be members of differentgroups of trial eye-contact devices. Corresponding features aregenerally indicated by reference numerals increased by 5000. The variousgroups of trial-contact devices may differ from one another by theirdevice parameters such as, for example, diameter D_(device) and/or bythe shape of trial proximal device surface 5103B (e.g., the curvature ofconcave-shaped proximal surface 5103B). While FIGS. 5A and 5Bschematically illustrates a trial set 500 that includes two devicegroups 1 and 2 which differ from each other by their trial devicediameter D_(trial-device) (D1 _(trail-device)<D2 _(trial-device)) only,this should by no means be construed limiting. Optionally, trial kit 500may comprise more than 2 groups of trial eye-contact devices allowingtrial of various combinations of device diameters and shape of proximaldevice surface 5103B to cover and conformably fit onto the patient'scornea 208. For instance, considering four different diameters and eightdifferent curvatures of proximal device surface 5103B, a trial set 500may comprise 32 groups of trial eye-contact devices 510.

As schematically shown in FIGS. SA and 5B, at least one group or eachgroup of trial eye-contact device may comprise one or more subsets oftrial devices, exemplified in FIGS. 5A and 5B by the two subsets A and B(e.g., group 1-A and group 1-B). Each subset may be defined by adifferent sized diameter d_(transmissive) of “trial” light-transmissiveportion 5104.

Considering for instance that D_(device1)=8 mm and d_(transmissive)=1mm, the first subset A of group 1 may comprise 4 trial devices 510-1 to510-4 in which trial light-transmissive portion 5104 is respectivelyshifted from the center of trial devices by 1 mm, 2, mm, 3 mm, and 4 mmfrom the center (left side of FIG. 5A).

Considering now for example that D_(device1)=8 mm andd_(transmissive)=0.5 mm, then the second subset B of group 1 maycomprise 8 trial devices 510-5 to 510-12 in which for each trial device510, trial light-transmissive portion 5104 is displaced from the centerO of trial device by 0.5 mm, 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4mm from the center. The relative displacement of triallight-transmissive portions 5104 in the different trial devices 510 isschematically indicated by broken circular lines.

Clearly, the configuration or setup of trial kit 500 referred to hereinshould not be construed in a limiting manner. Accordingly, alternativetrial set configurations may be employed.

Optionally, a first trial set may be provided for selecting the devicehaving a suitable diameter and proximal device surface 5103B, and secondtrial set may be provided for selecting the size and/or orientation oftrial light-transmissive portion 5104.

In an embodiment, a trial kit may comprise compartments 520 (e.g.,compartments 520A-520X) configured to receive trial eye-contact devices510 and indicate information, for example, about device diameter,curvature of trial proximal device surface 5103B, diameter of triallight-transmissive portion 5104 received in respective compartments 520,etc. Optionally, trial kit 500 comprises trial eye-contact devices 510which are sorted, e.g., in compartments 520, according to the differentdesign parameters of trial eye-contact devices 510.

Optionally, trial kit 500 may comprise various trial eye-contact devicesthat can allow the user to test various devices to determine whichdevice parameters can at least partially correct or at least partiallyor fully compensate for refractive errors of eye 200. That is inaddition to causing propagation of light 50 via light-transmissiveportion 104 to be incident (e.g., focus) onto new main vision spot 203,which is different from macula 205.

Optionally, once the device's diameter D_(device) and curvature of trialproximal device surface 5103B suitable for a given patient has beendetermined, the user selects of trial set 500 a trial eye-contactdevices having a given light transmissive aperture and, additionally,the suitable diameter D_(device) and curvature of trial proximal devicesurface 5103B. The selected eye-contact devices may be operablypositioned on the patient's eye 200 by the user and rotated (e.g., bythe user) 360 degrees (in clockwise or counterclockwise directionrelative to the patient eye's optical axis Z_(eye)). Optionally, duringrotation or after a certain degree of rotation has been imparted on theselected trial eye-contact devices by the user (e.g., manually) relativeto the patient's cornea 208, the given patient may be asked to gaze atan eye chart and to provide feedback. Based on the provided feedback,his/her visual acuity may be determined for the corresponding rotationalposition and diameter of light-transmissive portion 104 on his/her eye200. This procedure may be repeated for a variety of selected trialeye-contact devices, e.g., in an iterative manner, until the parametersfor manufacturing a definite eye-contact device possessing optimalparameters for the given patient are determined. Additional oralternative eye-acuity testing systems and/or methods may be employed.

In some embodiments, the procedures and methods outlined herein may beperformed to improve a patient's mono-vision capabilities.

In some embodiments, the above procedures may first be accomplished forone of the two eyes of the patient that is comparatively more adverselyaffected by a medical condition. In some other embodiments, the aboveprocedures may first be accomplished for one of the two eyes of thepatient that is comparatively less adversely affected by a medicalcondition.

In some embodiments, the definite other eye-contact device may beprovided or manufactured so that for the same patient, a new left mainvision spot 203L and new right main vision spot 203R correspond witheach other to allow the patient's brain to construct a single image.

Additionally referring to FIG. 6, a method for obtaining informationpertaining to the (e.g., clinical) condition of a patient's eye 200 maycomprise, for example, selecting at least two of a plurality of trialeye-contact devices. Each one of the at least two selected trialeye-contact devices has different design parameters (step 602).

The method may then further include applying or operably engaging the atleast two selected trial eye-contact devices with the same eye 200 ofthe patient (step 604).

The method including rotating the at least two selected trialeye-contact devices by 360 degrees on the patient's eye (Step 606) andreceive a feedback from the patient (step 608).

The method may further include selecting another trial-eye contactdevice based on the feedback received from the patient (step 610).Optionally, the other trial-eye contact device may have designparameters which differ from the design parameters of any of the trialeye-contact devices selected in preceding steps. Optionally, the othertrial-eye contact device may be identical to one of the previouslyselected trial eye-contact devices. Optionally, the other trial-eyecontact device is selected such to improve the patient's acuity and/orcomfort.

As indicated by step 612, the method may include repeating steps 604 to608 until, taking for instance into consideration the patient's feedbackand available trial devices, optimal results are obtained, e.g., withrespect to visual acuity and/or patient comfort.

Unless otherwise stated, the use of the expression “and/or” between thelast two members of a list of options for selection indicates that aselection of one or more of the listed options is appropriate and may bemade.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments or example,may also be provided in combination in a single embodiment. Conversely,various features of the invention, which are, for brevity, described inthe context of a single embodiment, example and/or option, may also beprovided separately or in any suitable subcombination or as suitable inany other described embodiment, example or option of the invention.Certain features described in the context of various embodiments,examples and/or options are not to be considered essential features ofthose embodiments, unless the embodiment, example and/or option isinoperative without those elements.

It is noted that the term “exemplary” is used herein to refer toexamples of embodiments and/or implementations, and is not meant tonecessarily convey a more-desirable use-case.

The number of elements shown in the Figures should by no means beconstrued as limiting and is for illustrative purposes only.

While the invention has been described with respect to a limited numberof embodiments, these should not be construed as limitations on thescope of the invention, but rather as exemplifications of some of theembodiments.

As used herein, unless otherwise specified, the use of the ordinaladjectives “first”, “second”, etc., to describe like objects, merelyindicate that different instances of like objects are being referred to,and are not intended to imply that the objects so described must be in agiven sequence, temporally, in ranking, and/or in any other manner.

It should be understood that where the claims or specification refer to“a” or “an” element and/or feature, such reference is not to beconstrued as there being only one of that element. Hence, reference to“an element” or “at least one element” for instance may also encompass“one or more elements”.

The terms “substantially,” “substantial,” and the like refer to aconsiderable degree or extent. When used in conjunction with an event orcircumstance, the terms can refer to instances in which the event orcircumstance occurs precisely as well as instances in which the event orcircumstance occurs to a close approximation, such as accounting fortypical tolerance levels or variability of the embodiments describedherein.

It should be noted that the term “light” or “visible light” as usedherein may refer to electromagnetic radiation of any suitable wavelengthfor the purposes of the applications disclosed herein. For example, theterm “light” may include a wavelength range of electromagnetic radiationthat can be seen by a healthy visual system of humans or other mammals.

Throughout this application, various embodiments of this invention maybe presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theinvention. Accordingly, the description of a range should be consideredto have specifically disclosed all the possible subranges as well asindividual numerical values within that range. For example, descriptionof a range such as from 1 to 6 should be considered to have specificallydisclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numberswithin that range, for example, 1, 2, 3, 4, 5, and 6. This appliesregardless of the breadth of the range.

Whenever a numerical range is indicated herein, it is meant to includeany cited numeral (fractional or integral) within the indicated range.The phrases “ranging/ranges between” a first indicate number and asecond indicate number and “ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and aremeant to include the first and second indicated numbers and all thefractional and integral numerals therebetween.

While the invention has been described with respect to a limited numberof embodiments, these should not be construed as limitations on thescope of the invention, but rather as exemplifications of some of theembodiments.

1. A trial kit comprising a plurality of trial eye-contact devices eachhaving different values relating to optical design parameters of thetrial eye-contact devices such to allow a user of the trial kit tosequentially select at least two of the plurality of trial eye-contactdevices for implementing an iterative optimization process in whichvalues pertaining to the optical design parameters are convergent untila combination of device parameters is determined that is consideredoptimal for a given patient, each of said trial eye-contact devicescomprising: a contact lens body having a rotational symmetry axis thatvirtually intersects a location on the retina lying within a radius of anon-dilated pupil, the contact lens body having a distal device surfaceand a proximal device surface, comprising: an opaque portion; and alight-transmissive portion consisting of a single pinhole that isoperable to direct light from the distal device surface to the proximaldevice surface along an optical axis that is different from the symmetryaxis of the contact lens body, wherein the optical axis of the singlepinhole intersects a second location of the retina exceeding the radiusof the non-dilated pupil, wherein when the contact lens body operablyengages an eye having an optical axis, the rotational symmetry axiscoincides with the optical axis of the eye, and further wherein thecontact lens body comprising the light-transmissive portion isconfigured to direct light propagating through the light-transmissiveportion such to be incident onto the second location that is within theeye's macula but not on the fovea located in the macula.
 2. The trialkit of claim 1, wherein said optical design parameters are selected froma device diameter, a curvature of the proximal device surface, adiameter of the light transmissive portion, displacement of the lighttransmissive portion from a center of the device or any combinationthereof.
 3. The trial kit of claim 1, further comprising compartmentsconfigured receive each of the trial eye-contact devices and to indicateinformation about the optical design parameters of each of the trialeye-contact devices.
 4. A method for obtaining information pertaining tothe clinical condition of an eye of a given patient: selecting at leasttwo of a plurality of trial eye-contact devices according to claimwherein each of the at least two selected trial eye-contact devices hasdifferent optical design parameters; applying the at east two selectedtrial eye-contact devices with the same eye of the given patient;rotating the at least two selected trial eye-contact devices by 360degrees on the eye of the given patient; receiving a feedback for thegiven patient regarding visual acuity and patient comfort; selectinganother trial-eye contact device based on the feedback received from thegiven patient; and repeating the applying, rotating and receivingfeedback until optimal visual acuity and/or patient comfort per thegiven patient are determined.
 5. The method of claim 4, wherein saidoptical design parameters are selected from a device diameter, acurvature of the proximal device surface, a diameter of the lighttransmissive portion, displacement of the light transmissive portionfrom a center of the device or any combination thereof.
 6. The method ofclaim 4, wherein the another trial-eye contact device has optical designparameters which differ from the optical design parameters of any of thetrial eye-contact devices selected in preceding operations.
 7. Themethod of claim 4, wherein the another trial-eye contact device isidentical to one of the trial eye-contact devices selected in precedingoperations.
 8. The method of claim 4, further comprising manufacturing adefinite eye-contact device possessing the optical design parametersthat correspond to the determined optimal visual acuity and/or patientcomfort per the given patient.